Published online Feb 06, 2024.
https://doi.org/10.4111/icu.20230283
Mid-term results of ReMEEX sling system in female stress urinary incontinence with various indications and feasibility of readjustment
Abstract
Purpose
To examine efficacy and safety of ReMEEX implantation in patients with female stress urinary incontinence (SUI) associated with detrusor underactivity (DU), recurrence, or intrinsic sphincter deficiency (ISD).
Materials and Methods
Retrospective cohort study included 303 females who underwent ReMEEX system (March 2008 to May 2021). Patients were stratified into three groups by purpose of surgery (SUI with DU, reoperation, and SUI with ISD) and evaluated with following criteria: cure (absence of subjective complaint of leakage and objective leakage in the stress test), improvement (rare leakage subjectively, but satisfaction regardless of stress test), and failure. Primary outcome was success rate of surgery assessed through patient interviews and a stress test. Surgical outcomes and complications were evaluated.
Results
Mean follow-up was 34.4 months (range, 6.0–145.0 months). At the final follow-up visit, 42.9% and 49.2% of patients were cured and improved. Twenty-one point five percent required tension readjustment (mean number, 1.2). The total complication rate was 19.5% (none for grade ≥4). Preoperative Qmax was significantly higher in the ISD group (p<0.001) and preoperative total International Prostate Symptom Score (IPSS) score was significantly higher in the DU group (p=0.044). Moreover, at postoperative 1 year, both total IPSS score and IPSS quality of life score were significantly higher in the DU group (both p=0.001).
Conclusions
The success rate of ReMEEX system was 92.1% at mean follow-up of 34.4 months in female SUI with DU, reoperation, or ISD. It also enabled postoperative readjustment of sling tension, as needed, up to 130 months after surgery.
Graphical Abstract
INTRODUCTION
Stress urinary incontinence (SUI) is associated with severe social, economic, and psychological challenges that can have a significantly negative influence on female health. The evolution of mid-urethral slings with high efficacy and safety has led to the application of retropubic midurethral slings and transobturator midurethral slings in urology [1]. Determining the optimal balance of incontinence/obstruction is a crucial step in ensuring appropriate tension during mid-urethral sling operation. The tension re-adjustable mid-urethral sling, ReMEEX sling system™ (Neomedic International), with re-adjustable sling tension immediately postoperatively or several months and even years after initial surgery, strongly facilitates the management of patients with recurrent SUI, intrinsic sphincter deficiency (ISD), or voiding dysfunction such as an underactive bladder. There are some studies that suggest that Remeex may be beneficial in cases of concomitant SUI and detrusor underactivity (DU) [1, 2]. Chung and Yoo [1] reported that the ReMEEX system facilitates both the positioning of the sling with adequate tension during surgery and the loosening or tightening of the sling postoperatively to achieve continence and maintain adequate voiding function, allowing it to be used for patients with voiding difficulties such as DU. Ko et al. [2] showed a success rate of 81.5% for female patients with SUI and DU who underwent the ReMEEX system. However, ReMEEX implantation may increase the amount of foreign body of the remedy device, being more than a midurethral sling, and the probability of suprapubic wound infection. Unfortunately, clinical trials and evidence evaluating the efficacy of ReMEEX system for recurrent SUI with ISD are still scarce [3]. Recent evidence suggests that ReMEEX system may have higher success rates than the transvaginal tape in recurrent SUI [4]. Our study assessed the efficacy and safety of implantation of ReMEEX system in female SUI with DU, recurrence, or ISD.
MATERIALS AND METHODS
1. Patients
As a retrospective cohort study, the study cohort included 303 female patients who underwent ReMEEX system between March 2008 and May 2021 at Seoul National University Bundang Hospital. Patients were assessed before surgery by physical examination, urinalysis, free uroflow, stress test, 1-hour pad test, pressure-flow studies and some questionnaires. Questionnaires included International Prostate Symptom Score (IPSS), and overactive bladder symptom score (OABSS). IPSS questionnaire is a feasible tool for evaluating lower urinary tract symptoms in women [5, 6]. As for IPSS, the symptom index comprises seven questions on urinary frequency, incomplete emptying, weak urinary stream, intermittency, hesitancy, urgency, and nocturia. The quality of life (QoL) index is scored based on the patient’s symptoms utilizing a scale of 0 to 6. Severity was categorized according to the sum of the seven questions’ scores as mild (score 0 to 7), moderate (8 to 19), and severe (20 to 35). A lower QoL score means a better quality of life. As for OABSS, it contains questions about the 4 symptoms (daytime frequency, nighttime frequency, urgency, and urge incontinence). The total score ranges from zero to fifteen, with a higher score indicating a more severe overactive bladder (OAB) [7].
They were classified into three groups by purpose of surgery (SUI with DU, reoperation for SUI, and SUI with ISD). Generally, DU was defined by reduced strength±duration that leads to prolonged bladder emptying±failure to empty completely within an adequate time span, based on the 2002 International Continence Society standardization report [8]. Specifically for this study, DU was defined by a maximum flow rate (Qmax) value of ≤12 mL/s and detrusor pressure at Qmax (PdetQmax) of ≤10 cmH2O during the pressure-flow study [9, 10]. Women who displayed urinary frequency (≥8 voids/24 hours), urgency (≥6 episodes/3 days), or urge incontinence (≥3 episodes/3 days) were diagnosed with OAB [10, 11]. The case of recurrence was the failure of the previous surgery for genuine SUI. ISD was defined as abdominal leak point pressure <60 cmH2O (Valsalva leak-point pressure [VLPP] was utilized) or maximum urethral closure pressure (MUCP) <20 cmH2O [12].
Primary outcome was the success rate of surgery assessed through patient interviews and a stress test. Based on postoperative symptoms through the stress test and thorough patient interview by physicians or qualified research assistants, patients were stratified into those who were cured (absence of subjective complaints of leakage and absence of leakage during the stress test), those who showed improvement (rare leakage subjectively, but satisfaction irrespective of the stress test), and those who failed (use of any treatment for postoperative incontinence and all other outcomes) [13].
The inclusion criteria were (1) aged ≥18 years, (2) meeting one of three conditions: SUI with DU based on pressure-flow studies, recurrent SUI after failed anti-incontinence surgery, and VLPP <60 cmH2O or MUCP <20 cmH2O based on pressure-flow studies, (3) ≥6 months of follow-up after ReMEEX surgery. The exclusion criteria were presence of lower urinary tract pathologies such as interstitial cystitis, bladder tumors, urinary tract calculus, clinically significant bladder outlet obstruction (Qmax ≤12 mL/s and PdetQmax ≥25 cmH2O with sustained detrusor contraction based on a pressure-flow study) [14], and symptomatic or recurrent urinary tract infections. Subjects who had a neurogenic cause underlying OAB were also excluded. All the patients fulfilled the inclusion criteria. The study was approved by the Institutional Review Board (IRB) of Seoul National University Bundang Hospital (approval number: B-2202-737-108) and the written informed consent was waived by the IRB due to the retrospective nature of the study. This study was conducted in accordance with the Declaration of Helsinki.
2. Perioperative evaluation
Preoperative evaluation entailed a detailed past medical history, a 3-day frequency-volume chart, physical examination, urine analysis and culture, stress test, and pressure-flow study, which included the measurement of maximal cystometric capacity, VLPP, detrusor pressure at peak urinary flow, MUCP, uroflowmetry, and postvoid residual urine (PVR). A multichannel urodynamic study (UD2000; Medical Measures System) (pressure-flow study included) were performed according to the International Continence Society guidelines [15]. The results of uroflowmetry were accepted when the voided urine volume was ≥150 mL, with correctly measured PVR by ultrasound and adequately generated voiding curve.
SUI was objectively determined utilizing 1-hour pad test, according to the protocol devised by Abrams et al. [8]. To conduct the pad test, patients were directed to consume half a liter of water and place a pre-weighed absorbent on a scale with an accuracy of 0.0001 g. After a lapse of 30 minutes, patients were asked to ambulate up and down stairs and ramps for 10 minutes; undertake 10 repetitions of getting up and down from a seated position; cough forcibly ten times; engage in a 1-minute run; bend to pick up an object from the floor 5 times, and finally wash their hands under tap water for 1 minute. After one hour, the absorbent was removed and weighed, and the difference between the values was recorded. Based on this test, urinary incontinence was classified into four grades: grade 1, test pad weight <10 g; grade 2, pad test weight 11–50 g; grade 3, pad test weight 51–100 g; and grade 4, pad test weight >100 g [16].
The stress test was performed at the position of 45 degree sitting or standing after filling the bladder with 200 to 250 mL of normal saline. The stress test was regarded as positive when urine leakage was demonstrated in relation to abdominal straining or coughing [10].
3. Surgical procedures
A readjustable midurethral sling surgery was carried out utilizing the ReMEEX system by a single surgeon. The ReMEEX device comprised a suburethral polypropylene prosthesis linked to a pressure adjusting device (varitensor) by 2 traction threads. The varitensor was permanently implanted in the fascia of the rectus abdominis muscle. The postoperative sling tension was adjusted by connecting the varitensor to the manipulator. The surgery was performed under spinal or general anesthesia with the patient held in the dorsal lithotomy position. The anterior vaginal wall was incised from the mid-urethral area to the urethrovesical junction, approximately 2 cm, and then dissected from the underlying periurethral tissues to the endopelvic fascia. A transverse suprapubic incision of 3 cm was subsequently made, exposing the rectus abdominis muscles’ fascia without opening it. A top-to-bottom technique was used to tunnel and place sling sutures. A cystoscopy was performed to ensure that the bladder was not perforated. The traction threads were passed through the eye of a needle and drawn upward on each side until the abdominal incision. A polypropylene mesh was located at the mid-urethral level. The traction threads were inserted into the varitensor and tied together. The manipulator was then rotated clockwise until the varitensor remained 3.5 cm above the rectus sheath without tension. The abdominal and vaginal incisions were closed with the manipulator protruding via the abdominal incision.
Patients were evaluated on the day following surgery. They were asked whether they were able to urinate without any difficulty by checking voided volume and PVR. Patients were also asked to perform a cough test or any activity that generally resulted in SUI. Usually, three to four times of cough and straining were performed, but if in case of no evidence of urine leakage, then we directed the patient to jump in place 3–4 times to identify urine leakage without bladder filling [13]. These tests were performed in the urology laboratory by a qualified nurse. If there was a urine leakage, the sling was tightened by rotating the manipulator until no further leak occurred without significant residual urine. The manipulator was removed after the continence had been reached.
4. Follow-up
Follow-up appointments were arranged at 1, 3, 6, and 12 months, followed by subsequent annual appointments. Each follow-up evaluation comprised uroflowmetry with PVR measurement, and a stress test to measure the incontinence degree. If urine leakage was found, the ReMEEX system was adjusted as follows. The patient was positioned under local anesthesia. The manipulator was reattached to the varitensor via prior abdominal incision, and the sling tension was re-adjusted. Subjective patient surgical outcomes were defined as follows: “cure” if no urinary incontinence occurred, whereas “improvement” in urinary incontinence was quite unnoticeable and rare. All the other outcomes were defined as “failure.” All perioperative complications were analyzed utilizing the modified Clavien–Dindo classification.
5. Statistical analysis
The baseline characteristics and postoperative outcomes of groups were compared and analyzed retrospectively. The frequencies and proportions of each categorical variable were compared using Fisher’s exact tests or chi-square test, as appropriate. For continuous variables, means and standard deviations were compared utilizing one-way ANOVA after normality and variance-equivalence tests. All statistical tests were performed at a 2-sided significance level of 0.05 utilizing IBM SPSS version 22.0 (IBM Corp.). A p<0.05 was regarded as statistically significant.
RESULTS
Table 1 lists the baseline characteristics of all patients and patients in each group. A total of 303 patients underwent ReMEEX surgery, with 145 for DU, 48 for reoperation, and the remaining 110 for ISD. The overall treatment success rate was 92.1% (42.9% cure and 49.2% improvement), and there was no significant difference in success rates based on the purpose of surgery (p=0.980) (Table 2).
Table 1
Baseline characteristics
Table 2
Outcomes of ReMEEX sling system
The median final follow-up was 25.0 months (range, 6–145 months). The differences in baseline characteristics among groups were not significant except for the mean follow-up duration (DU: 28.8±25.2 months, reoperation: 32.8±28.4 months, and ISD: 45.0±35.4 months, p<0.001). No significant differences were detected in postvoid residual urine (p=0.209 and p=0.700), IPSS QoL score (p=0.069 and p=0.619), and total OABSS score (p=0.818 and p=0.097) between groups before surgery and at postoperative 2 years, respectively (Tables 1, 2). On the other hand, preoperative Qmax was significantly higher in the ISD group (25.3 mL/s vs. 11.4 in DU group vs. 24.7 in reoperation group, p<0.001) and preoperative total IPSS score was significantly higher in the DU group (17.5 vs. 14.9 in reoperation group vs. 15.6 in ISD group, p=0.044) (Table 1). Moreover, at postoperative 1 year, both total IPSS score and IPSS QoL score were significantly higher in the DU group (both p=0.001) (Table 2).
At the final follow-up visit, 130 patients (42.9%) were cured, 149 patients (49.2%) were improved and 24 patients (7.9%) failed treatment. At a mean follow-up period of 34.4±31.5 months, 65 patients (21.5%) required sling tension readjustment (mean number, 1.2) (Table 2). The total complication rate (any grade) was 19.5% without complication ≥grade 4. Complications included voiding difficulty requiring catheterization (52/303, 17.2%), wound dehiscence (10/303, 3.3%), and severe leg pain (Severe leg pain was defined as lower limb pain scoring ≥7 on the visual analogue scale, likely induced by being placed in the lithotomy position during surgery [17].) (3/303, 1.0%) (Table 3). Each complication has been treated as follows: For voiding difficulty that requires catheterization, clean intermittent catheterization with alpha blockers were administered for several weeks. For wound dehiscence, oral antibiotics were prescribed along with reinforced adhesive skin closure tape. In cases of severe leg pain, a consultation with an anesthesiologist for neural pain block was performed. De novo urgency was controlled by pharmacologic treatment. All complications were resolved within few months following the surgical procedure.
Table 3
Complications of ReMEEX sling system according to Clavien–Dindo grade
DISCUSSION
Determining the optimal balance between incontinence and obstruction is a crucial step in determining the level of tension during the mid-urethral sling operation. Most studies involving surgery with the Remeex® system reported higher cure rates than the present study, with 71.7% to 90% of patients reporting an absence of urine leakage during the cough stress test or the 24-hour pad weight test <2 g [4, 18, 19, 20]. There are several reasons for this difference. We selected the ReMEEX candidates including patients only with DU, recurrent SUI after previous SUI surgery, or with ISD. As there are no obvious recommendations for management of recurrent SUI or ISD [21, 22, 23], the indications for ReMEEX might vary according to surgeon’s personal preference. Patients with SUI alone are usually advised to undergo transobturator sling surgery instead of ReMEEX, and most patients prefer the former. The addition of SUI-only patients is expected to increase efficacy significantly compared to the findings of the current study. Nevertheless, our findings provide data associated with the safety of the ReMEEX® readjustable sling with an acceptable number of complications compared with other studies. Ko et al. [2] reported 27 patients with the ReMEEX system for SUI and DU and 11 cases of minor complications. They also reported 7 patients without postoperative urine leakage requested ReMEEX removal due to intractable postoperative urinary retention within one year meanwhile there is none in our cohort due to same reason. Park et al. [18] showed results of 102 women with ReMEEX for previous failed surgery or ISD from multicenter study. They concluded 95.1% of success rate (89.2% cure and 5.9% improvement) although 40.2% experienced minor complications. Errando-Smet et al. [20] reported long-term good results of 205 ReMEEX patients with recurrent SUI and ISD. Eighty and a half percent of success rate was achieved with 28.8% of overall complications rate (3.4% Clavien–Dindo grade III). Our general complication rate (19.5%) is comparable to that of other studies, ranging from 31.7% to 51.1% [2, 18, 20, 24, 25, 26]. Readjustment of the ReMEEX® system was performed in 21.5% of our patients, which was comparable to findings reported in other studies (15.6%–42.9%) [1, 18, 20, 24, 26].
No consensus is available regarding the precise tension needed for adjustable sling procedure in each patient. Nevertheless, surgeons performing ReMEEX require extensive knowledge regarding appropriate sling implantation techniques to minimize the number of unexpected adverse outcomes. The greatest advantage of the ReMEEX is its readjustment capacity to reach an optimal tension for each female, reducing and even avoiding possible re-interventions [27]. Our readjustment rate (21.5%) is higher than in other studies (7%–10% during 11.7–60.6 months) [4, 19, 28]. Patients’ psychological factor might contribute to our readjustment rate. In the case of our cohort, it is believed that close communication with physicians is better achieved through indepth interviews conducted at every postoperative follow-up visit. Therefore, readjustment might be conducted more frequently due to less pressure or burden on readjustment. Also, from the patient's perspective, it is believed that even if there was an improvement, readjustment would have been carried out after consultation because they wanted a more perfect cure. Nonetheless, one patient was readjusted to reach continence 130 months after surgery, suggesting the durability and safety of ReMEEX system.
Our study is limited by retrospective design. In addition, it was difficult to confirm how the abnormal preoperative urodynamic findings (e.g., VLPP or Qmax) changed in postoperative period, as postoperative pressure-flow studies were not routinely evaluated. The inability to identify preoperative predictors of favorable surgical outcomes is another limitation.
Our aim was to ascertain if there existed any variation in subjective surgical results across the three groups. It is regrettable that we could not perform this analysis since there were no instances where ReMEEX was performed on patients with SUI solely. We acknowledge this as another limitation of the study. In addition, our finding of the success rate of more than 90% in complicated SUI requires further investigation to determine whether the results of ReMEEX in simple SUI are comparable to those in complicated SUI. The last limitation is that in-depth patient interviews and stress tests are used as tools to evaluate the success rate of surgery instead of standardized questionnaires. Nevertheless, regular surveys were conducted using IPSS and OABSS questionnaires to assess the postoperative condition of patients. However, one of our strengths is that ours is one of the few studies showing that readjustment can be done to meet patients’ needs even 10 years after surgery. We also analyzed a relatively long-term cohort with a mid-term follow-up. In addition, it can be argued that ReMEEX is an appropriate option for even patients with complicated SUI, based on a satisfaction rate of 90%.
CONCLUSIONS
The ReMEEX system resulted in a success rate of 92.1% at a mean follow-up of 34.4 months in female SUI with DU, reoperation, or ISD. The ReMEEX system also enabled postoperative readjustment of sling tension as needed, up to 130 months after surgery. Our midterm outcomes are comparable to those reported in other studies, with comparable rate of complications. Well-designed and prospective studies with a careful preoperative assessment may improve cure rates in patients with complicated SUI.
CONFLICTS OF INTEREST:The authors have nothing to disclose.
FUNDING:None.
AUTHORS’ CONTRIBUTIONS:
Research conception and design: Hwanik Kim and Seong Jin Jeong.
Data acquisition: Hwanik Kim, Jin Hyuck Kim, and Seong Jin Jeong.
Statistical analysis: Hwanik Kim, Jin Hyuck Kim, and Seong Jin Jeong.
Data analysis and interpretation: Hwanik Kim, Jin Hyuck Kim, and Seong Jin Jeong.
Drafting of the manuscript: Hwanik Kim and Seong Jin Jeong.
Critical revision of the manuscript: Hwanik Kim and Seong Jin Jeong.
Administrative, technical, or material support: Hwanik Kim and Seong Jin Jeong.
Supervision: Seong Jin Jeong.
Approval of the final manuscript: all authors.
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